length of stay after transfemoral transcatheter aortic...
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J A C C : C A R D I O V A S C U L A R I N T E R V E N T I O N S V O L . 1 2 , N O . 5 , 2 0 1 9
ª 2 0 1 9 B Y T H E A M E R I C A N C O L L E G E O F C A R D I O L O G Y F O U N D A T I O N
P U B L I S H E D B Y E L S E V I E R
Length of Stay After TransfemoralTranscatheter Aortic ValveReplacement
An Analysis of the Society of Thoracic Surgeons/American College of CardiologyTranscatheter Valve Therapy RegistrySiddharth A. Wayangankar, MD,a Islam Y. Elgendy, MD,a Qun Xiang, MS,b Hani Jneid, MD,c
Sreekanth Vemulapalli, MD,b Tigran Khachatryan, MD,d Don Pham, MD,e Anthony A. Hilliard, MD,d
Samir R. Kapadia, MDf
JACC: CARDIOVASCULAR INTERVENTIONS CME/MOC/ECME
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Length of Stay After Transfemoral Transcatheter Aortic Valve Replacement:
An Analysis of the Society of Thoracic Surgeons/American College of
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From the aDivision of Cardiovascular Medicine, Department of Medicine, U
diovascular Research Institute, Durham, North Carolina; cDivision of Car
Houston, Texas; dDivision of Cardiovascular Medicine, Loma Linda Unive
Hospital, Houston, Texas; and the fDepartment of Cardiology, Cleveland Clin
Medtronic Valve therapies. All other authors have reported that they have n
to disclose.
Manuscript received October 4, 2018; revised manuscript received Novembe
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CME/MOC/ECME Objective for This Article: Upon completion of this
activity, the learner should be able to: 1) understand the incidence of longer
length of stay after TAVR; 2) identify risk factors for longer length of stay
after TAVR; and 3) understand the relationship between length of stay and
outcomes after TAVR.
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Author Disclosures: Dr. Wayangankar is a proctor for Medtronic Valve
therapies. All other authors have reported that they have no relation-
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https://doi.org/10.1016/j.jcin.2018.11.015
niversity of Florida, Gainesville, Florida; bDuke Car-
diovascular Medicine, Baylor College of Medicine,
rsity, Loma Linda, California; eMemorial Hermann
ic, Cleveland, Ohio. Dr. Wayangankar is a proctor for
o relationships relevant to the contents of this paper
r 13, 2018, accepted November 14, 2018.
J A C C : C A R D I O V A S C U L A R I N T E R V E N T I O N S V O L . 1 2 , N O . 5 , 2 0 1 9 Wayangankar et al.M A R C H 1 1 , 2 0 1 9 : 4 2 2 – 3 0 LOS After TAVR
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Length of Stay After Transf
emoralTranscatheter Aortic Valve ReplacementAn Analysis of the Society of Thoracic Surgeons/American College of CardiologyTranscatheter Valve Therapy Registry
Siddharth A. Wayangankar, MD,a Islam Y. Elgendy, MD,a Qun Xiang, MS,b Hani Jneid, MD,c
Sreekanth Vemulapalli, MD,b Tigran Khachatryan, MD,d Don Pham, MD,e Anthony A. Hilliard, MD,d
Samir R. Kapadia, MDf
ABSTRACT
OBJECTIVES The goal of this study was to investigate the trends, predictors, and outcomes of delayed discharge
(>72 h) after transcatheter aortic valve replacement.
BACKGROUND Length of stay post–transcatheter aortic valve replacement may have significant clinical and admin-
istrative implications.
METHODS Data from the Transcatheter Valve Therapy Registry were used to identify patients undergoing nonaborted
transfemoral transcatheter aortic valve replacement who survived to discharge, and data linked from the Centers for
Medicare & Medicaid Services were used to provide 1-year events. Patients were categorized to early discharge (#72 h)
versus delayed discharge (>72 h). The trends, predictors, and adjusted 1-year outcomes were compared in both groups.
RESULTS From 2011 to 2015, a total of 13,389 patients (55.1%) were discharged within 72 h, whereas 10,896 patients
(44.9%) were discharged beyond 72 h. There was a significant decline in rates of delayed discharge across the study
period (62% vs. 34%; p < 0.01). This remained unchanged when stratified by Transcatheter Valve Therapy risk scores.
Several factors were identified as independent predictors of early and delayed discharge. After adjustment for in-hospital
complications, delayed discharge was an independent predictor of 1-year all-cause mortality (hazard ratio: 1.45; 95%
confidence interval: 1.30 to 1.60; p < 0.01).
CONCLUSIONS Rates of delayed discharge have declined from 2011 to 2015. Delayed discharge is associated with a
significant increase in mortality even after adjusting for in-hospital complications. Further work is necessary to determine
if predictors of early discharge could be used to develop length of stay scores that might be instrumental in adminis-
trative, financial, or clinical policy development. (J Am Coll Cardiol Intv 2019;12:422–30) © 2019 by the American
College of Cardiology Foundation.
T ranscatheter aortic valve replacement(TAVR) has emerged as a suitable alternativefor surgical aortic valve replacement for in-
termediate- to high-risk patients with severe aorticstenosis (1–5). Recent enhancement in techniques,devices, and improved operator experience haslargely contributed to the improved outcomes andlower procedure-related complications with TAVR(6). These improvements have led to a more wide-spread adoption of a “minimalist” approach usingmonitored anesthesia care/local anesthesia andavoidance of post-procedure intensive care stay forselective transfemoral (TF) TAVRs (7). The biggest
push behind this “minimalist approach” has been tolimit direct procedural costs, but more importantlyto abbreviate the length of stay (LOS) thereby mini-mizing post-procedure costs; the latter being a largecontributor to total TAVR costs. Because the proced-ures are becoming less invasive, the LOS after theprocedure is expected to become shorter. Severalsingle-center studies have suggested that an earlydischarge strategy (<72 h) is safe and feasible afterTF-TAVR (8–10). A strategy of early discharge isimportant from administrative and financial view-points. Thus, the aim of this study was to investigatethe trends, predictors, and outcomes of delayed
SEE PAGE 431
TABLE 1 Baseline Characteristi
Delayed Discharge Groups
Age $85 yrs
Female
RaceWhite non-HispanicBlack non-HispanicHispanicOther
Prior infective endocarditis
Prior permanent pacemaker
Previous ICD
Prior PCI
Prior CABG
Prior aortic valve procedure
Prior mitral valve procedure
Prior stroke or TIA
Peripheral arterial disease
Current/recent smoker
Hypertension
Diabetes mellitus
Severe lung disease
Home oxygen
Immunocompromised
Prior MI
Heart failure in past 2 weeks
NYHA functional class IV
Inotropic/mechanical support
Prior atrial fibrillation/flutter
Hemodialysis
Tricuspid valve morphology
Aortic valve insufficiencyNone/mildModerate/severe
ABBR EV I A T I ON S
AND ACRONYMS
LOS = length of stay
MI = myocardial infarction
STS/ACC TVT = Society of
Thoracic Surgery/American
College of Cardiology
Transcatheter Valve Therapy
Registry
TAVR = transcatheter aortic
valve replacement
TF = transfemoral
Wayangankar et al. J A C C : C A R D I O V A S C U L A R I N T E R V E N T I O N S V O L . 1 2 , N O . 5 , 2 0 1 9
LOS After TAVR M A R C H 1 1 , 2 0 1 9 : 4 2 2 – 3 0
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discharge ($72 h) after TAVR using a nation-ally representative dataset.
METHODS
DATA SOURCE. The Society of Thoracic Sur-gery/American College of Cardiology Trans-catheter Valve Therapy (STS/ACC TVT)Registry was founded in 2011. Facilities per-forming TAVR procedures are required tosubmit commercial cases to the registry forMedicare reimbursement. The data are linked
with inpatient Medicare administrative claims by theCenters for Medicare and Medicaid Services usingdirected patient identifiers. The TVT Registry con-tains clinical information including patient baseline
cs of Patients With Early Discharge and
Total(N ¼ 24,285)
EarlyDischarge
(n ¼ 13,389)
DelayedDischarge
(n ¼ 10,896) p Value
9,868 (40.6) 5,275 (39.4) 4,593 (42.1) <0.001
10,332 (42.5) 5,281 (39.4) 5,051 (46.3) <0.001
<0.00121,566 (88.8) 11,991 (89.5) 9,575 (87.9)
895 (3.7) 413 (3.1) 482 (4.4)937 (3.8) 462 (3.4) 475 (4.3)887 (3.6) 523 (3.9) 364 (3.3)
271 (1.1) 144 (1.1) 127 (1.2) 0.51
3,904 (16.1) 2,285 (17.1) 1,619 (14.8) <0.001
1,155 (4.7) 684 (5.1) 471 (4.3) 0.004
8,449 (34.8) 4,730 (35.3) 3,719 (34.1) 0.04
7,119 (29.3) 4,155 (31.0) 2,964 (27.2) <0.001
3,424 (14.1) 1,897 (14.2) 1,527 (14.0) 0.72
603 (2.5) 265 (2.0) 338 (3.1) <0.001
4,163 (17.1) 2,291 (17.1) 1,872 (17.2) 0.88
5,705 (23.5) 3,099 (23.1) 2,606 (23.9) 0.15
1,081 (4.4) 617 (4.6) 464 (4.2) 0.19
21,497 (88.5) 11,840 (88.4) 9,657 (88.6) 0.65
9,069 (37.3) 4,918 (36.7) 4,151 (38.1) 0.03
2,942 (12.1) 1,466 (10.9) 1,476 (13.5) <0.001
2,615 (10.8) 1,229 (9.2) 1,386 (12.7) <0.001
2,467 (10.1) 1,351 (10.1) 1,116 (10.2) 0.69
5,735 (23.6) 3,240 (24.2) 2,495 (22.9) 0.02
18,638 (76.7) 10,147 (75.8) 8,491 (77.9) <0.001
4,233 (17.4) 2,079 (15.5) 2,154 (19.8) <0.001
9,964 (41.0) 5,193 (38.8) 4,771 (43.8) <0.001
9,539 (39.3) 4,997 (37.3) 4,542 (41.7) <0.001
945 (3.9) 441 (3.3) 504 (4.6) <0.001
21,691 (89.3) 12,014 (89.7) 9,677 (88.8) 0.02
0.8619,148 (78.8) 10,561 (78.9) 8,587 (77.8)4,944 (21.2) 2,720 (21.1) 2,224 (21.2)
Continued on the next page
demographics, comorbidities, functional status, andprocedural details, and 1-year outcomes using stan-dardized definitions on all patients undergoing TAVRat a participating facility. This approach of acquiringthe data and ascertainment of events in the STS/ACCTVT Registry has been previously published (6,11).The Duke University School of Medicine institutionalreview board granted a waiver of informed consentfor this study.
STUDY COHORT. For the purpose of this study, weincluded all patients $18 years who underwentTF-TAVR from November 1, 2011 to September 30,2015, from the TVT Registry. Patients were excludedif: 1) they died during the hospitalization; 2) theprocedure was aborted or canceled; or 3) they weretransferred or discharged to any facility other thanhome (because some institutions might choose todischarge patients to another facility as a method toartificially lower the LOS). Based on the hospital LOS,patients were categorized into early discharge group(i.e., discharge within #72 h) or delayed dischargegroup (i.e., discharge beyond 72 h).
OUTCOMES. The 1-year individual outcomesincluded time to event occurrence of all-cause mor-tality, myocardial infarction (MI), and stroke. Thecomposite endpoint included a composite of majoradverse cardiac events, defined as the composite ofall-cause mortality, MI, stroke, or major bleeding.The data for these outcomes were obtained throughMedicare administrative claims records for rehospi-talization for these events using International Clas-sification of Diseases-9th Revision (n ¼ 12,479)-Clinical Modification codes for MI (410.x0 and410.x1) and stroke (433.x1, 434.x1, 997.02, 436, 437.1,437.9, 430, 431, and 432.x).
STATISTICAL ANALYSIS. Baseline characteristicsand in-hospital complications were presented for theearly discharge versus the delayed discharge groups.Categorical variables were reported as percentages.The baseline characteristics and in-hospital compli-cations of the early discharge group and delayeddischarge group were compared using Pearson chi-square test for categorical variables. Multivariablelogistic regression models with generalized esti-mating equation were constructed to estimate oddsratios and corresponding 95% confidence intervals forearly or delayed discharge. A robust covariance ma-trix estimator was used to account for the effect ofcluster between the hospitals. We calculated theincidence of the delayed discharges in each quarteracross the study period, with the total number of
FIGURE 1 Series Plot of DD Over Time
Rate of DD by quarter. Patients discharged to home. DD ¼ delayed discharge.
TABLE 1 Continued
Total(N ¼ 24,285)
EarlyDischarge
(n ¼ 13,389)
DelayedDischarge
(n ¼ 10,896) p Value
Mitral valve insufficiency <0.001None/mild 17,450 (71.8) 9,760 (72.3) 7,690 (70.6)Moderate/severe 6,688 (28.2) 3,541 (27.7) 3,147 (29.4)
Mitral stenosis 1,172 (4.8) 616 (4.6) 556 (5.1) 0.06
Concurrent PCI 325 (100) 169 (52.0) 156 (48.0) 0.04
Procedure location <0.001Hybrid OR suite 14,360 (59.1) 7,633 (57.0) 6,727 (61.7)Hybrid catheterization laboratory
suite7,044 (29.0) 4,031 (30.1) 3,013 (27.6)
Catheterization laboratory 2,793 (11.9) 1,684 (12.9) 1,109 (10.7)
Total site volume <0.0010–99 5,375 (22.1) 3,139 (23.4) 2,236 (20.5)100–199 7,317 (30.1) 4,098 (30.6) 3,219 (29.5)200–399 9,213 (37.9) 4,851 (36.2) 4,362 (40.0)>400 2,380 (9.9) 1,301 (9.8) 1,079 (10.0)
Valve-in-valve 948 (3.9) 597 (4.4) 351 (3.2) <0.001
Anesthesia type <0.001Moderate sedation 2,783 (11.4) 1,913 (14.3) 870 (8.0)General anesthesia 21,312 (87.8) 11,366 (84.9) 9,946 (91.2)Other 127 (0.9) 75 (0.8) 52 (0.8)
Valve sheath access method <0.001Percutaneous 15,776 (65.0) 9,346 (69.8) 6,430 (59.0)Cutdown 8,403 (34.6) 4,017 (30.0) 4,386 (40.2)Other 88 (0.4) 15 (0.2) 73 (0.8)
5-m test <0.001Unable to walk or >10 s 6,134 (25.2) 2,976 (22.2) 3,158 (29.0)#10 s 11,929 (49.1) 7,216 (53.9) 4,713 (43.2)
Values are n (%).
CABG ¼ coronary artery bypass surgery graft; ICD ¼ implantable cardioverter-defibrillator; MI ¼ myocardialinfarction; NYHA¼ New York Heart Association; OR ¼ operating room; PCI ¼ percutaneous coronary intervention;TIA ¼ transient ischemic attack.
J A C C : C A R D I O V A S C U L A R I N T E R V E N T I O N S V O L . 1 2 , N O . 5 , 2 0 1 9 Wayangankar et al.M A R C H 1 1 , 2 0 1 9 : 4 2 2 – 3 0 LOS After TAVR
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TF-TAVR procedures as the denominator. TheCochran-Armitage test was used to show the proba-bility of delayed discharge rates over time. The trendanalyses were stratified based on the STS PredictedRisk of Operative Mortality score.
Kaplan-Meier analyses were used to compute theincidences of death and nonfatal outcomes at 1-yearpost-TAVR for patients in the early discharge anddelayed discharge groups. For the survival analysesof the nonfatal outcomes, such as stroke and MI, weincorporated the competing effect of death on the riskof these outcomes using Gray test (12). A Cox pro-portional hazards model was applied to examine theassociation of LOS and the outcomes at 1 year. Themodel was adjusted for variables listed in OnlineTable 1. The risk of outcomes of interest for those inthe early discharge versus delayed discharge groupswere reported using hazard ratios with 95% confi-dence interval. All statistical analyses were conduct-ed using SAS version 9.4 (SAS Institute Inc., Cary,North Carolina), and a p < 0.05 was considered sta-tistically significant for all analyses.
RESULTS
STUDY POPULATION. During the study period fromNovember 1, 2011, to September 30, 2015, a total of24,285 patients underwent nonaborted TF-TAVR andsurvived to discharge: 13,389 patients (55.1%) weredischarged within 72 h (i.e., early discharge group),whereas 10,896 patients (44.9%) were dischargedbeyond 72 h (i.e., delayed discharge group). Data forCenters for Medicare & Medicaid Services linkage forthe 1-year outcomes were available for 12,479 patients(51.4% of the entire cohort). The median follow-upestimate was 365 days (Q1, 217; Q3, 365). Table 1summarizes the baseline characteristics of patientsin both groups. Patients in the early discharge groupwere older, men, white, had diabetes, had a history ofMI, prior revascularization (percutaneous coronaryintervention or coronary artery bypass surgery), andwere more likely to have a history of prior pacemakeror defibrillator and a previous history of aortic valveprocedure. Patients in the late discharge group werelikely to have underlying severe lung disease, orhistory of mitral valve procedure.
TEMPORAL TRENDS OF DELAYED DISCHARGE.
During the study period, there was a significantdecline in the rates of delayed discharge (62.2% in the2012 Q1 vs. 34.4% 2015 Q3; p < 0.01) (Figure 1). Thisdecline in the rates of delayed discharge was notedduring the study period across every STS PredictedRisk of Operative Mortality score subgroup (Figure 2).
FIGURE 2 Series Plot of DD Over Time by STS PROM Risk Score
Rates of delayed discharge by quarter by risk group. Patients discharged to home. Blue
line ¼ STS PROM <4%; red line ¼ STS PROM 4% to 8%; green line ¼ STS PROM 8% to
15%; brown line ¼ STS PROM >15%; PROM ¼ Predicted Risk of Operative Mortality score;
STS ¼ Society of Thoracic Surgeons; other abbreviation as in Figure 1.
TABLE 2 Predictors of Delayed Discharge
Odds Ratio(95% CI) p Value
Age $85 yrs 1.14 (1.07–1.22) <0.001
Female 1.16 (0.76–1.78) 0.48
RaceBlack vs. white 1.30 (1.12–1.52) 0.0007Hispanic vs. white 1.18 (1.04–1.34) 0.0079Other vs. white 1.00 (0.85–1.17) 0.9726
LVEF per 5 units 0.99 (0.97–1.00) 0.04
Prior infective endocarditis 0.97 (0.74–1.27) 0.82
Prior permanent pacemaker 0.74 (0.68–0.80) <0.001
Previous ICD 0.80 (0.70–0.92) 0.001
Prior PCI 1.00 (0.95–1.06) 0.94
Prior CABG 0.89 (0.84–0.95) 0.0003
Prior aortic valve procedure 1.01 (0.91–1.13) 0.82
Prior mitral valve procedure 1.62 (1.35–1.95) <0.001
Prior stroke or TIA 0.99 (0.93–1.06) 0.83
Peripheral arterial disease 1.09 (1.01–1.18) 0.03
Smoker 0.86 (0.75–1.00) 0.05
Hypertension 1.01 (0.93–1.11) 0.76
Diabetes mellitus 1.09 (1.03–1.15) 0.004
Severe lung disease 1.10 (1.01–1.20) 0.03
Home oxygen 1.32 (1.20–1.46) <0.001
Immunocompromised 0.97 (0.87–1.08) 0.59
Heart failure in last 2 weeks 1.05 (0.97–1.15) 0.23
Continued on the next page
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LOS After TAVR M A R C H 1 1 , 2 0 1 9 : 4 2 2 – 3 0
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PREDICTORS OF EARLY AND DELAYED DISCHARGE.
Table 2 depicts the predictors of delayed dischargeafter multivariate analyses. Age $85 years, AfricanAmericans, Hispanics, patients with prior mitralvalve procedures, presence of diabetes, home oxy-gen, New York Heart Association functional class IV,cardiogenic shock, need for ionotropes, need formechanical support, atrial fibrillation, dialysis,glomerular filtration rate <30, right ventricular sys-tolic pressure >60 mm Hg, institutional volume 200to 399 cases/year, cut down access technique, >10 son walk test, and use of self-expanding valve wereindependent predictors for delayed discharge. Incontrast, presence of prior intracardiac devices, priorcoronary artery bypass surgery, smokers, prior MI,valve-in-valve, and percutaneous access were inde-pendent predictors of early discharge.
OUTCOMES AT 1 YEAR. Figure 3A shows the com-parison of outcomes based on LOS. The composite ofdeath, stroke, MI, or bleeding was significantly higherin patients who had delayed discharge compared withearly discharge. This was mainly driven by increasedmortality in the former group. Delayed dischargepost-TAVR was significantly associated with higher 1-year all-cause mortality with separation of curvesnoted immediately post-procedure (Figure 3B). Theresults of survival analysis (adjusted and unadjusteddata) on mortality and cumulative incidence ofnonfatal outcomes at 1-year without, and with in-hospital complication are shown in Table 3. Asobserved from the tables, even after adjusting for in-hospital complications, delayed discharge was an in-dependent predictor of 1-year all-cause mortality(hazard ratio: 1.45; 95% confidence interval: 1.30 to1.60; p < 0.01).
DISCUSSION
This is the first large-scale study looking into LOSpost-TF-TAVR. Our study showed that from 2011 to2015 around 55% of the patients were dischargedwithin 72 h. There was a significant decline in rates ofdelayed discharge across the study period (62% vs.34%; p < 0.01). Regardless of whether patients hadpost-procedural complications or not, delayeddischarge was an independent predictor of increased1-year all-cause mortality (hazards ratio: 1.45; 95%confidence interval: 1.30 to 1.60; p < 0.01).
DECLINE IN DELAYED DISCHARGE. Our studyshowed that on an average, more than one-half of theTF-TAVRs end up having delayed discharge duringthe study period. However, it is encouraging to notethat the prevalence of delayed discharge has shown a
TABLE 2 Continued
Odds Ratio(95% CI) p Value
Prior MI 0.91 (0.85–0.99) 0.02
NYHA functional class IV 1.20 (1.10–1.31) <0.001
Inotropic/mechanical support 1.16 (1.07–1.26) <0.001
Atrial fibrillation/flutter 1.17 (1.10–1.24) <.0001
GFR and dialysisOn dialysis vs. GFR $60 1.42 (1.22–1.65) <0.001GFR <30 vs. GFR $60 1.58 (1.38–1.80) <0.001GFR 30–59.9 vs. GFR $60 1.18 (1.11–1.26) <0.001
RVSP40–60 vs. <40 1.05 (0.97–1.13) 0.21$60 vs. <40 1.37 (1.24–1.51) <0.0001
Tricuspid aortic valve 0.92 (0.80–1.05) 0.2209
Aortic insufficiency (moderate/severe) 0.93 (0.87–1.00) 0.05
Mitral insufficiency (moderate/severe) 1.00 (0.94–1.07) 0.93
Tricuspid insufficiency (moderate/severe) 1.06 (0.99–1.13) 0.12
Mitral stenosis 1.01 (0.89–1.15) 0.86
Valve-in-valve 0.72 (0.59–0.87) <0.001
Procedure locationHybrid catheterization laboratory vs. hybrid OR 0.86 (0.75–0.99) 0.03Catheterization laboratory vs. hybrid OR 0.94 (0.76–1.16) 0.54Other vs. hybrid OR 1.24 (0.59–2.61) 0.58
Total valve volume100–199 vs. 0–99 1.22 (0.99–1.50) 0.06200–399 vs. 0–99 1.36 (1.05–1.76) 0.02>400 vs. 0–99 1.35 (0.56–3.23) 0.50
Cutdown vs. percutaneous 1.72 (1.53–1.93) <0.001
Anesthesia typeModerate sedation vs. general anesthesia 0.51 (0.44–0.60) <0.001Other vs. general anesthesia 0.84 (0.54–1.30) 0.42
Unable to walk or >10 s on walk test 1.28 (1.19–1.37) <0.001
Core valve vs. Sapien valve 1.53 (1.40–1.67) <0.001
CI ¼ confidence interval; GFR ¼ glomerular filtration rate; LVEF ¼ left ventricular ejection fraction; RVSP ¼ rightventricular systolic pressure; other abbreviations as in Table 1.
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consistent decline from 2011 to 2015 (62% to 34%).The biggest drop was noted across 2014 Q2 (about10%). Although the financial feasibility of TAVR wasalways questioned since its inception, it was during2014 to 2016 that the concept of “minimalistic TAVR”gained wider acceptance. Appropriate patient selec-tion, modified monitored anesthesia care, post-procedure care in post-anesthesia care units, andlower threshold to remove temporary pacemakerpost-procedure have all significantly helped in-stitutions curtail operating costs. More importantly,this trend persisted when patients were analyzedstratified based on the STS risk (Figure 2). This speaksto the nationwide system-based changes aiming tooptimize TAVRs that have been universally adoptedby all TAVR programs across the country. Thesechanges that were designed to optimize TAVR (andimprove financial and administrative feasibility ofTAVR programs) have had an indirect effect innegating the effect of high TVT scores on LOS in pa-tients undergoing TF-TAVR.
PREDICTORS OF DELAYED DISCHARGE. Advanced age($85 years) was found to be an independent predictorfor delayed discharge. Advanced age is usually asso-ciated with advanced frailty, lower functional capac-ity, increased burden of comorbidities, and higherrisk for periprocedural vascular and nonvascularcomplications, all factors that can delay discharge tohome (13). A testimony to this fact that is that >10 son walk test (a surrogate marker for frailty) wasindependently associated with delayed discharge inour study. Also, our study excluded patients dis-charged to nursing homes, a feature common in oc-togenarians and nonagenarians post-surgery oradvanced procedures. Hence the impact of age ondischarge to home may actually be underestimated inour study. As observed in many other cardiovascularstudies (14), racial disparity in outcomes wasobserved in our study as well. African American andHispanic race were associated with delayeddischarge. Whether this was caused by increaseddisease burden in certain races or related to differ-ential demographic and clinical variables amongdifferent races remains a matter of speculation. Ourstudy shows interesting phenomena with respect toLOS and institutional volume. Institutions perform-ing 200 to 399 cases per year were associated withdelayed discharge. This phenomenon was notobserved when institutions performed <100 cases peryear or >400 cases per year. A combination of patientselection and proficiency of TAVR programs may beresponsible for this observed effect. The institutionsperforming <100 cases per year are relatively lower
volume centers who prefer to super-select certainstraightforward TAVR cases or might chose moreappropriate cases and therefore have minimal impacton delayed discharge. However, institutions >400cases per year despite potentially receiving high-riskcase referrals have years of experience and havetherefore streamlined their TAVR programs, whicheffectively blunts the effect of high-risk cases ondelayed discharge. Institutions who are in betweenare in a transition phase where they are trying to in-crease their institutional volumes but have not yetperfected the art of careful patient selection; hencethe strong association with delayed discharge. Inter-estingly, the use of self-expanding valves was foundto be a predictor for delayed discharge. We believethis may have been related to the practice of keepingtemporary pacemakers for >48 h post-procedurein every patient with core-valve, a mandated
FIGURE 3 Outcomes Based on Length of Stay
(A) Incidence of the unadjusted outcomes (Kaplan-Meier estimates for death and the composite and cumulative incidence function for the nonfatal outcomes in the
presence of death as a competing risk) in both groups. (B) Kaplan-Meier plot of 1-year all-cause mortality in both groups. With number of subjects at risk and 95%
confidence limits. ED ¼ early discharge; TAVR ¼ transcatheter aortic valve replacement; other abbreviation as in Figure 1.
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LOS After TAVR M A R C H 1 1 , 2 0 1 9 : 4 2 2 – 3 0
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requirement in some of the self-expanding valve tri-als. In addition, some centers still practice surgicalcut down when using self-expanding valves, whichmight be another contributor for the delayeddischarge seen with this type of device.
PREDICTORS OF EARLY DISCHARGE. Interestingly, pa-tients with prior MI or prior coronary artery bypasssurgery were found to be independent predictors forearly discharge. The reason for this paradox is un-known but favorable outcomes within the same sub-group have been noted in prior studies withcardiogenic shock patients undergoing percutaneouscoronary intervention (15). In the latter study, itseemed that patients with prior coronary artery dis-ease and revascularization did better than naive pa-tients when they underwent percutaneous coronary
TABLE 3 Survival Analysis on Mortality and Nonfatal Outcomes at 1
Unadjusted Estimates
HR (95% CI) p Value H
All-cause mortality 1.55 (1.39–1.72) <0.0001 1.45
Stroke 1.10 (0.84–1.46) 0.49 1.09
Myocardial infarction 0.98 (0.73–1.32) 0.89 0.97
In-hospital bleeding 1.42 (1.29–1.56) <0.0001 1.32
Composite 1.42 (1.32–1.53) <0.0001 1.34
CI ¼ confidence interval; HR ¼ hazard ratio.
intervention for cardiogenic shock and theauthors in that study attributed to the benefit toischemic pre-conditioning and better integration ofthese patients into local medical systems because oftheir prior coronary artery disease. It is hencepossible that a similar benefit may have accrued inour study patients. Another group of patients whoseemed to have had an impact on the early dischargefavorably were the patients with prior intracardiacdevices. This may have been driven by lesser need forprolonged in-hospital electrical monitoring favoringexpedited discharge. An early discharge in patientswith moderate-severe aortic insufficiency may beexplained by dual hemodynamic benefit of treating 2coexisting valvular lesions. A smoker’s paradox wasalso noted with regards to LOS. This has been noted ina few cardiovascular outcome studies; however, the
Year
Adjusted EstimatesAdjusted
(With In-Hospital Complications)
R (95% CI) p Value HR (95% CI) p Value
(1.30–1.62) <0.0001 1.44 (1.29–1.61) <0.0001
(0.82–1.44) 0.56 1.09 (0.82–1.44) 0.56
(0.71–1.31) 0.83 0.96 (0.71–1.30) 0.77
(1.20–1.46) <0.0001 1.32 (1.19–1.45) <0.0001
(1.24–1.45) <0.0001 1.34 (1.24–1.44) <0.0001
PERSPECTIVES
WHAT IS KNOWN? LOS post-TAVR may have significant clin-
ical and administrative implications.
WHAT IS NEW? LOS for patients undergoing transfemoral
TAVR has significantly decreased from 2011 to 2015. Delayed
discharge is associated with a significant increase in mortality
even after adjusting for in-hospital complications.
WHAT IS NEXT? Predictors of early/delayed discharge could be
used to develop LOS scores, which might be instrumental in
administrative, financial, or clinical policy development.
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exact mechanism for this effect remains speculativeat best. Valve-in-valve therapies seem to do betterbecause the native heart (electrical, circulatory, andannular structure) is relatively protected by the priorsurgical valve and most common reasons for delay indischarge are therefore mitigated (16). Finally,percutaneous access to TF-TAVR has allowed efficientoptimization of TF-TAVR procedures and helped byobviating general anesthesia, expedited early recov-ery, mobilization, and hence early discharge post-procedure. These predictors (of delayed and earlydischarge) could be used to develop risk scores thatcould be used by clinicians for appropriate patientselection and use of resources by administrators, in-surance companies, and policy makers to formulatestratified bundle payments for TAVR procedures infuture.
OUTCOMES. One of the most clinically significantfinding in our study is that the LOS does have sig-nificant association with short- and long-term out-comes. The Kaplan-Meier curves demonstrated thatpatients with delayed discharge had significantlyworse 1-year outcomes compared with earlydischarge cohort. Although this could be as a result ofresidual uncaptured difference in terms of patients’risk profile, the adjusted analyses also demonstratedthat early discharge is associated with a lower 1-yearmortality. Delayed discharge portends a significantlyhigher risk of composite of death, stroke, MI, andbleeding compared with early discharge. This effectwas mainly driven by increased mortality andbleeding (requiring hospitalization) in the formergroup. Because procedural complications have hugeimplications on LOS and morbidity and mortality, weanalyzed our data for outcomes with/withoutadjusting for occurrence of complications and foundsimilar results. This is significant and indicates thatregardless of the occurrence of procedural complica-tions, delayed discharges are a group of TF-TAVRpatients who are at higher risk for mortalitycompared with the early discharge group. Develop-ment of pre-procedural and post-procedural riskscores would help in proper patient selection andmore importantly post-procedurally help in planningcloser follow-up and more rigorous risk factor modi-fication in the delayed discharge to mitigate the riskof higher mortality.
STUDY LIMITATIONS. First, this study is observa-tional in nature. Despite applying statistical analysesto adjust for the differences in the baseline charac-teristics and in-hospital complications, the risk of
residual confounding could not be entirelyexcluded. Second, although there is standardizationand uniformity in the TVT Registry, the data areonly internally validated at sites and not centrallyadjudicated. Third, the field of TF-TAVR had rapidchanges in patient selection, techniques, and post-procedural care; hence, our study results may notentirely be representative of the current practicestandards. Finally, the 1-year outcome data weredriven from an administrative database, thus theoutcomes might have been overestimated. However,this approach has been adopted in previous studiesfrom the TVT Registry (6,11) and other NationalCardiovascular Data Registry databases.
CONCLUSIONS
This is the first study that describes the patterns ofLOS post-TAVR from a large nationwide database.LOS post-TF-TAVR has significantly decreased from2011 to 2015; and with continued refinement intechniques and patient selection, we anticipate thistrend would continue. Predictors of delayeddischarge and early discharge could be used by cli-nicians, administrators, and third-party payers tobetter serve this ever-expanding field of percuta-neous valve therapies. Finally, regardless of thepresence of procedure-related complications,delayed discharge is associated with a significant riskof mortality at 1 year.
ADDRESS FOR CORRESPONDENCE: Dr. Siddharth A.Wayangankar, Division of Cardiovascular Medicine,Department of Medicine, University of Florida, 7919SW 79th Drive, Gainesville, Florida 32610. E-mail:[email protected].
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RE F E RENCE S
1. Smith CR, Leon MB, Mack MJ, et al. Trans-catheter versus surgical aortic-valve replacementin high-risk patients. N Engl J Med 2011;364:2187–98.
2. Adams DH, Popma JJ, Reardon MJ, et al.Transcatheter aortic-valve replacement with aself-expanding prosthesis. N Engl J Med 2014;370:1790–8.
3. Leon MB, Smith CR, Mack MJ, et al. Trans-catheter or surgical aortic-valve replacement inintermediate-risk patients. N Engl J Med 2016;374:1609–20.
4. Reardon MJ, Van Mieghem NM, Popma JJ, et al.Surgical or transcatheter aortic-valve replacementin intermediate-risk patients. N Engl J Med 2017;376:1321–31.
5. Pagnesi M, Chiarito M, Stefanini GG, et al. Istranscatheter aortic valve replacement superior tosurgical aortic valve replacement?: a meta-analysis of randomized controlled trials. J AmColl Cardiol Intv 2017;10:1899–901.
6. Holmes DR Jr., Brennan JM, Rumsfeld JS, et al.Clinical outcomes at 1 year following transcatheteraortic valve replacement. JAMA 2015;313:1019–28.
7. Durand E, Borz B, Godin M, et al. Transfemoralaortic valve replacement with the Edwards SAPIENand Edwards SAPIEN XT prosthesis using exclu-sively local anesthesia and fluoroscopic guidance:
feasibility and 30-day outcomes. J Am Coll CardiolIntv 2012;5:461–7.
8. Durand E, Eltchaninoff H, Canville A, et al.Feasibility and safety of early discharge aftertransfemoral transcatheter aortic valve implanta-tion with the Edwards SAPIEN-XT prosthesis. Am JCardiol 2015;115:1116–22.
9. Serletis-Bizios A, Durand E, Cellier G, et al.A prospective analysis of early discharge aftertransfemoral transcatheter aortic valve implanta-tion. Am J Cardiol 2016;118:866–72.
10. Barbanti M, Capranzano P, Ohno Y, et al. Earlydischarge after transfemoral transcatheter aorticvalve implantation. Heart 2015;101:1485–90.
11. Mack MJ, Brennan JM, Brindis R, et al. Out-comes following transcatheter aortic valvereplacement in the United States. JAMA 2013;310:2069–77.
12. Gray RJ. A class of K-sample tests forcomparing the cumulative incidence of acompeting risk. Ann Stat 1988;16:1141–54.
13. Arsalan M, Szerlip M, Vemulapalli S, et al.Should transcatheter aortic valve replacement beperformed in nonagenarians?: insights from theSTS/ACC TVT Registry. J Am Coll Cardiol 2016;67:1387–95.
14. Wayangankar SA, Kennedy KF, Aronow HD,et al. Racial/ethnic variation in carotid arteryrevascularization utilization and outcomes:
analysis from the National Cardiovascular DataRegistry. Stroke 2015;46:1525–32.
15. Wayangankar SA, Bangalore S, McCoy LA,et al. Temporal trends and outcomes of pa-tients undergoing percutaneous coronary in-terventions for cardiogenic shock in the settingof acute myocardial infarction: a report fromthe CathPCI Registry. J Am Coll Cardiol Intv2016;9:341–51.
16. Tuzcu EM, Kapadia SR, Vemulapalli S,et al. Transcatheter aortic valve replacementof failed surgically implanted bioprostheses:the STS/ACC Registry. J Am Coll Cardiol 2018;72:370–82.
KEY WORDS length of stay, major adversecardiac event(s), mortality, transcatheteraortic valve replacement
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